Cyanotic infant sensor

ABSTRACT

A pulse oximetry sensor comprises emitters configured to transmit light having a plurality of wavelengths into a fleshy medium. A detector is responsive to the emitted light after absorption by constituents of pulsatile blood flowing within the medium so as to generate intensity signals. A sensor head has a light absorbing surface adapted to be disposed proximate the medium. The emitters and the detector are disposed proximate the sensor head. A detector window is defined by the sensor head and configured so as to limit the field-of-view of the detector.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority benefit under 35 U.S.C. §120 to,and is a continuation of U.S. patent application Ser. No. 13/100,145,filed May 3, 2011 entitled “Cyanotic Infant Sensor,” now U.S. Pat. No.8,682,407, which is a continuation of U.S. patent application Ser. No.11/171,632, filed Jun. 30, 2005 entitled “Cyanotic Infant Sensor,” nowU.S. Pat. No. 7,937,128, which claims priority benefit under 35 U.S.C.§119(e) from U.S. Provisional Application No. 60/586,821, filed Jul. 9,2004, entitled “Cyanotic Infant Sensor.” The present application alsoincorporates the foregoing disclosures herein by reference.

BACKGROUND OF THE INVENTION

Cyanosis is a congenital condition in which blood pumped to the bodycontains less than normal amounts of oxygen, resulting in a bluediscoloration of the skin. The most common cyanotic condition istetralogy of Fallot, which is characterized by an abnormal opening, orventricular septal defect, that allows blood to pass from the rightventricle to the left ventricle without going through the lungs; anarrowing, or stenosis, proximate the pulmonary valve, which partiallyblocks the flow of blood from the right side of the heart to the lungs;a right ventricle that is abnormally muscular; and an aorta that liesdirectly over the ventricular septal defect. Another cyanotic conditionis tricuspid atresia, characterized by a lack of a tricuspid valve andresulting in a lack of blood flow from the right atrium to the rightventricle. Yet another cyanotic condition is transposition of the greatarteries, i.e. the aorta originates from the right ventricle, and thepulmonary artery originates from the left ventricle. Hence, most of theblood returning to the heart from the body is pumped back out withoutfirst going to the lungs, and most of the blood returning from the lungsgoes back to the lungs.

Pulse oximetry is a useful tool for diagnosing and evaluating cyanoticconditions. A pulse oximeter performs a spectral analysis of thepulsatile component of arterial blood so as to measure oxygensaturation, the relative concentration of oxygenated hemoglobin, alongwith pulse rate. FIG. 1 illustrates a pulse oximetry system 100 having asensor 110 and a monitor 140. The sensor 110 has emitters 120 and adetector 130 and is attached to a patient at a selected fleshy tissuesite, such as a thumb or toe. The emitters 120 project light through theblood vessels and capillaries of the tissue site. The detector 130 ispositioned so as to detect the emitted light as it emerges from thetissue site. A pulse oximetry sensor is described in U.S. Pat. No.6,088,607 entitled “Low Noise Optical Probe,” which is assigned toMasimo Corporation, Irvine, Calif. and incorporated by reference herein.

Also shown in FIG. 1, the monitor 140 has drivers 150, a controller 160,a front-end 170, a signal processor 180, a display 190. The drivers 150alternately activate the emitters 120 as determined by the controller160. The front-end 170 conditions and digitizes the resulting currentgenerated by the detector 130, which is proportional to the intensity ofthe detected light. The signal processor 180 inputs the conditioneddetector signal and determines oxygen saturation, as described below,along with pulse rate. The display 190 provides a numerical readout of apatient's oxygen saturation and pulse rate. A pulse oximetry monitor isdescribed in U.S. Pat. No. 5,482,036 entitled “Signal ProcessingApparatus and Method,” which is assigned to Masimo Corporation, Irvine,Calif. and incorporated by reference herein.

SUMMARY OF THE INVENTION

The Beer-Lambert law provides a simple model that describes a tissuesite response to pulse oximetry measurements. The Beer-Lambert lawstates that the concentration c_(i) of an absorbent in solution can bedetermined by the intensity of light transmitted through the solution,knowing the mean pathlength, mpl_(λ), the intensity of the incidentlight, I_(0,λ), and the extinction coefficient, ε_(i,λ), at a particularwavelength λ. In generalized form, the Beer-Lambert law is expressed as:

$\begin{matrix}{I_{\lambda} = {I_{0,\lambda}e^{{- {mpl}_{\lambda}} \cdot \mu_{a,\lambda}}}} & (1) \\{\mu_{a,\lambda} = {\sum\limits_{i = 1}^{n}{ɛ_{i,\lambda} \cdot c_{i}}}} & (2)\end{matrix}$

where μ_(a,λ)is the bulk absorption coefficient and represents theprobability of absorption per unit length. For conventional pulseoximetry, it is assumed that there are only two significant absorbers,oxygenated hemoglobin (HbO₂) and reduced hemoglobin (Hb). Thus, twodiscrete wavelengths are required to solve EQS. 1-2, e.g. red (RD) andinfrared (IR).

FIG. 2 shows a graph 200 depicting the relationship between RD/IR 202and oxygen saturation (SpO₂) 201, where RD/IR denotes the ratio of theDC normalized, AC detector responses to red and infrared wavelengths, asis well-known in the art and sometimes referred to as the“ratio-of-ratios.” This relationship can be approximated fromBeer-Lambert's Law, described above. However, it is most accuratelydetermined by statistical regression of experimental measurementsobtained from human volunteers and calibrated measurements of oxygensaturation. The result can be depicted as a curve 210, with measuredvalues of RD/IR shown on an x-axis 202 and corresponding saturationvalues shown on a y-axis 201. In a pulse oximeter device, this empiricalrelationship can be stored in a read-only memory (ROM) for use as alook-up table so that SpO₂ can be directly read-out from an input RD/IRmeasurement. For example, an RD/IR value of 1.0 corresponding to a point212 on the calibration curve 210 indicates a resulting SpO₂ value ofapproximately 85%.

Accurate and consistent pulse oximetry measurements on cyanotic infantshave been difficult to obtain. An assumption inherent in the calibrationcurve 210 (FIG. 2) is that the mean pathlength ratio for RD and IR isconstant across the patient population. That is:

mpl _(RD)/mpl_(IR) =C  (3)

However, EQ. 3 may not be valid when cyanotic infants are included inthat population. The reason may lie in what has been observed asabnormal tissue tone or lack of firmness associated with cyanoticdefects, perhaps due to reduced tissue fiber. Such differences in tissuestructure may alter the mean pathlength ratio as compared with normalinfants. A cyanotic infant sensor addresses these problems by limitingvariations in the RD over IR mean pathlength ratio and/or by providing amean pathlength ratio measure so as to compensate for such variations.Alone or combined, these sensor apparatus and algorithms increase theaccuracy and consistency of pulse oximetry measurements for cyanoticinfants.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a prior art pulse oximetry system;

FIG. 2 is an exemplar graph of a conventional calibration curve;

FIGS. 3A-B are a perspective and an exploded perspective views,respectively, of a cyanotic infant sensor embodiment;

FIGS. 4-5 depict cross-sectional views of a tissue site and an attachedpulse oximeter sensor, respectively;

FIG. 6 depicts a cross-sectional view of a tissue site and an attachedcyanotic infant sensor;

FIGS. 7A-B are plan and cross-sectional sensor head views of aconventional pulse oximeter sensor;

FIGS. 8A-B and 9A-B are plan and cross-sectional sensor head views ofcyanotic infant sensor embodiments; and

FIG. 10 is an exemplar graph of a calibration surface incorporating amean pathlength ratio measure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 3A-B illustrate one embodiment of a cyanotic infant sensor. Thesensor has a light absorbing surface, as described with respect to FIGS.4-6, below. The sensor also has a detector window configured to limitthe detector field-of-view (FOV), as described with respect to FIGS.7-9, below. Advantageously, these features limit mean pathlength ratiovariations that are particularly manifest in cyanotic patients.

The sensor emitters and detector are also matched so as to limitvariations in the detector red over IR DC response, i.e.RD_(DC)/IR_(DC), that are not attributed to variations in the meanpathlength ratio (EQ. 3). Such matching advantageously allows formeasurement and calibration of the mean pathlength ratio, as describedwith respect to FIG. 10, below. In one embodiment, cyanotic infantsensors 300 are constructed so that:

λ_(RD)≈c₁; λ_(IR)≈c₂  (4)

I _(0,RD) /I _(0,IR) ≈c ₃; for i _(DC)(RD), i _(DC)(IR)  (5)

RD _(DC) /IR _(DC) ≈c ₄  (6)

That is, sensors 300 are constructed from red LEDs and IR LEDs that areeach matched as to wavelength (EQ. 4). The LEDs are further matched asto red over IR intensity for given DC drive currents (EQ. 5). Inaddition, the sensors 300 are constructed from detectors that arematched as to red over IR DC response (EQ. 6).

As shown in FIG. 3A, the sensor 300 has a body 310 physically connectingand providing electrical communication between a sensor head 320 and aconnector 330. The sensor head 320 houses the emitters and detector andattaches to a patient tissue site. The connector mates with a patientcable so as to electrically communicate with a monitor. In oneembodiment, a sensor head surface 324 is constructed of light absorbingmaterial.

As shown in FIG. 3B, the sensor 300 has a face tape 330, a flex circuit340 and a base tape 360, with the flex circuit 340 disposed between theface tape 330 and the base tape 360. The flex circuit 340 has a detector342, an emitter 344 with at least two light emitting diodes (LEDs), aninformation element 346, and contacts 348 disposed on a connector tab349. Neonatal sensors having a detector, LEDs, an information element,contacts and connector tab are described in U.S. Pat. No. 6,256,523entitled “Low-Noise Optical Probes,” which is assigned to MasimoCorporation, Irvine, Calif. and incorporated by reference herein. In oneembodiment, the face tape 350 and base tape 360 are constructed ofBetham tape having attached polyethylene head tapes 351, 361. In aparticular embodiment, the base head tape 361 is made of blackpolyethylene, and the face head tape 351 is made of white polyethylene.In one embodiment, a clear tape layer is disposed on the base head tape361 tissue side over the detector window 362. The base head tape 361 hasa detector window 362 and an emitter window 364 each allowing light topass through the base head tape 361. In one embodiment, the base headtape 361 has a 4 mil thickness and the flex circuit has a 10 milthickness. The combined 14 mil material thickness functions to limit thedetector FOV, as described with respect to FIGS. 6 and 8, below.

FIGS. 4-6 illustrate some of the pathlength control aspects of acyanotic infant sensor 300. FIG. 4 depicts a fleshy tissue site 10 forsensor attachment, such as a finger or thumb 400. The tissue 10 has anepidermis 12, a dermis 14, subcutaneous and other soft tissue 16 andbone 18.

FIG. 5 depicts a conventional pulse oximetry sensor 20 having a detector22, an emitter 24 and a tape 26 attached to the fleshy tissue 10.Transmitted light 30 propagating from the emitter 24 to the detector 22that results in a significant contribution to pulse oximetrymeasurements passes through and is absorbed by the pulsatile blood inthe dermis 14. A portion of the transmitted light 30 is scattered out ofthe epidermis 12 and reflected by the tape 26 back into the fleshytissue 10. The detector field-of-view (FOV) 40 is relatively wide and,as a result, the detector responds to transmitted light 30 that haspropagated, at least in part, outside of the fleshy tissue 10.

FIG. 6 depicts a cyanotic infant sensor 300 that is configured to limitvariations in the mean pathlength ratio. In particular, the sensor 300has a light absorbing tape inner surface 324 that reduces transmittedlight reflection back into the tissue site 10, as described with respectto FIGS. 3A-B, above. Further, the detector 342 has a limited FOV 50 soas to reduce the detection of transmitted light that has propagatedoutside of the tissue site 10, as described in detail with respect toFIGS. 7-9, below.

FIGS. 8-9 illustrate cyanotic infant sensor embodiments having a limiteddetector field-of-view (FOV). FIGS. 7A-B illustrate a conventionalsensor 700 having a tape portion 760, a detector window 762 and adetector 742 having a relatively wide FOV 701. In particular, the windowthickness does little to restrict the FOV. FIGS. 8A-B illustrate oneembodiment of a cyanotic infant sensor 300 having a material portion360, a detector window 362 and a detector 342 having a restricted FOV801. In particular, the material thickness 360 functions to define theFOV 801. In one embodiment, the material thickness 360 comprises a flexcircuit thickness and a base head tape thickness, as described withrespect to FIG. 3B, above. FIGS. 9A-B illustrate another embodiment of acyanotic infant sensor 900 having a material portion 960, a detectorwindow 962 and a detector 942 having a restricted FOV 901. Inparticular, an O-ring 980 deposed around the window 962 defines the FOV901.

FIG. 10 depicts an exemplar calibration surface 1000 for a cyanoticinfant sensor 300 (FIGS. 3A-B) calculated along a DC response ratio axis1001, a ratio-of-ratios axis 1003 and a resulting oxygen saturation axis1005. Matching the emitters and detectors, as described with respect toFIG. 3A, above, allows for pathlength calibration. In particular,variations in the detector DC response ratio (RD_(dc)/IR_(dc)) areattributed to variations in the mean pathlength ratio (EQ. 3). As such,a calibration surface is determined by statistical regression ofexperimental measurements obtained from human volunteers and calibratedmeasurements of oxygen saturation, as is done for a conventionalcalibration curve (FIG. 2). A calculated DC response ratio 1001 incombination with a conventionally calculated ratio-of-ratios 1003 isthen used to derive an oxygen saturation 1005 for the calibrationsurface 1000.

A cyanotic infant sensor has been disclosed in detail in connection withvarious embodiments. These embodiments are disclosed by way of examplesonly and are not to limit the scope of the claims that follow. One ofordinary skill in art will appreciate many variations and modifications.

What is claimed is:
 1. A method for determining a physiologicalparameter, the method comprising: receiving one or more intensitysignals responsive to light of a plurality of wavelengths attenuated bybody tissue of a patient; electronically retrieving mapping dataincluding a relationship between DC response ratio data, ratio-of-ratiosdata, and oxygen saturation data; electronically calculating a DCresponse ratio value responsive to said one or more intensity signals;electronically calculating a ratio-of-ratios value responsive to saidone or more intensity signals; and electronically deriving an oxygensaturation measurement responsive to said mapping data.
 2. The method ofclaim 1, comprising electronically displaying the patient's oxygensaturation responsive to said oxygen saturation measurement.
 3. Themethod according to claim 1, wherein said calculating said DC responseratio comprises calculating said DC response ratio as a ratio of adetected incident intensity of the light at a first wavelength of saidplurality of wavelengths to a detected incident intensity of the lightat a second wavelength of said plurality of wavelengths.
 4. The methodaccording to claim 1, further comprising emitting said light from aplurality of emitters and receiving said light at one or more detectors.5. The method according to claim 4, wherein a first subset of theplurality of emitters have been matched to transmit light at a firstwavelength and a second subset of the plurality of emitters have beenmatched to transmit light at a second wavelength, wherein said matchingof said emitters to said first and second wavelengths reduces variationsin a mean pathlength ratio of said light traveling through said bodytissue between said plurality of emitters and said one or moredetectors.
 6. The method according to claim 4, wherein an emitted DCintensity ratio of said plurality of emitters has been matched to afirst predetermined constant, and wherein said matching of said emittedDC intensity ratio to said first predetermined constant further reducesvariations in said mean pathlength ratio of said light.
 7. The methodaccording to claim 4, further comprising receiving said light at one ormore detectors and generating said intensity signals from said lightreceived at said one or more detectors.
 8. The method according to claim7, wherein a DC response ratio of said one or more detectors has beenmatched to a second predetermined constant, and wherein said matching ofsaid DC response ratio to said second predetermined constant furtherreduces variations in said mean pathlength ratio of said light.
 9. Themethod according to claim 7, further comprising limiting a field-of-viewof said one or more detectors so as to substantially limit said lightreceived at said one or more detectors to portions of said light thatpropagate entirely through said body tissue.
 10. A pulse oximetercomprising one or more processors configured to execute the method ofclaim
 1. 11. The pulse oximeter of claim 10, further comprising aplurality of emitters configured to emit said light and one or moredetectors configured to detect said light.
 12. The pulse oximeter ofclaim 10, further comprising a memory, said memory storing said mappingdata.
 13. The pulse oximeter of claim 12, wherein said memory comprisesread only memory.
 14. A pulse oximeter comprising: a sensor configuredto output one or more intensity signals responsive to light attenuatedby body tissue of a patient wearing said sensor; a memory storingmapping data representing relationships between DC response data,ratio-of-ratios data, and oxygen saturation data; and a processorresponsive to said output signals to determine a DC response and aratio; said processor configured to determine a measurement valueresponsive to said relationships stored in said memory.
 15. The pulseoximeter of claim 14, further comprising a patient monitor housing forhousing said processor and said memory.
 16. The pulse oximeter of claim14, further comprising a sensor housing for housing said memory.
 17. Thepulse oximeter of claim 14, further comprising a display configured todisplay said measurement value.
 18. The pulse oximeter of claim 14,wherein said sensor comprises a plurality of emitters and one or moredetectors.
 19. The pulse oximeter of claim 18, wherein: a first subsetof the plurality of emitters are matched to transmit light at a firstwavelength and a second subset of the plurality of emitters are matchedto transmit light at a second wavelength; an emitted DC intensity ratioof said plurality of emitters is matched to a first predeterminedconstant; and a DC response ratio of said one or more detectors ismatched to a second predetermined constant; wherein said matching ofsaid emitters to said first and second wavelengths, said matching ofsaid emitted DC intensity ratio to said first predetermined constant,and said matching of said DC response ratio to said second predeterminedconstant reduces variations in a mean pathlength ratio of said lighttraveling through said body tissue between said plurality of emittersand said one or more detectors.
 20. The pulse oximeter of claim 14,wherein said memory comprises read only memory.